Primlev

Product NDC

24090-681

11-digit product format

240900681

Labeler code

24090

Product ID

24090-681_a3e037f0-fa7c-ba94-e053-2a95a90ab250

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

oxycodone and acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Akrimax Pharmaceuticals, LLC

Application

ANDA040608

Marketing category

ANDA

Marketing start

2011-12-01

Marketing end

2020-11-29

Substance

OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN

Active strength

5 mg/1; mg/1

Pharmacologic classes

Full Opioid Agonists [MoA],Opioid Agonist [EPC]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record